Novartis Menveo vaccine shows superior immune response against four types of meningitis disease in pivotal phase III trial
First Phase III, head-to-head data show Menveo may offer greater protection for adolescents compared to Menactra
New Phase III data for Menveo® (MenACWY-CRM) show that the vaccine produced a greater immune response against meningococcal serogroups A, C, W-135 and Y in adolescents 11-18 years of age compared to Menactra®. Infection with any of these four vaccine-preventable serogroups can lead to bacterial meningitis, an infection of the membrane around the brain and spinal cord, or sepsis, a serious infection of the blood stream. Results of this first head-to-head trial of Menveo compared to Menactra, show that adolescents who were immunized with Menveo generated higher levels of antibodies against all four serogroups.
Notably for serogroup Y, among adolescents with low levels of immunity at the time of vaccination, 81% of subjects receiving Menveo generated a protective immune response vs. 54% with Menactra, as measured by the hSBA assay. Serogroup Y causes approximately 39% of meningococcal disease cases in the US.
"To protect children against all major serogroups of meningococcal disease, we need vaccines that provide broad coverage and that can be used in all at-risk age groups," said Keith S. Reisinger, MD, MPH, Medical Director, Primary Physicians Research, Inc. Pittsburgh, PA. "These data are encouraging because they show that Menveo may provide greater protection for the more than 8 million infants and adolescents in the US against these four vaccine-preventable serogroups than the currently available vaccine."
Menveo is an investigational quadrivalent meningococcal conjugate vaccine in Phase III clinical development by Novartis Vaccines. The data were presented at a late-breaker platform session on May 5 during the 2008 Pediatric Academic Societies (PAS) Annual Meeting in Honolulu, Hawaii.
These data build on previous studies that demonstrated Menveo generates a strong protective immune response against these four vaccine-preventable serogroups in people across age groups from infancy to adulthood. Novartis expects to submit a Biologics License Application (BLA) to the US Food and Drug Administration later this year.
Menveo is currently in multiple Phase III clinical trials involving infants, young children, adolescents and adults. The vaccine is based on the same technology Novartis pioneered to produce Menjugate®, a meningococcal serogroup C conjugate vaccine approved outside the US since 2000 for use in individuals from two months of age through adulthood.
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